Systems and methods for transcatheter treatment of valve regurgitation

ABSTRACT

The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance devices for implantation across the valve; a system including the coaptation enhancement element and anchors for implantation; a system including the coaptation enhancement element, and one or more of the following: transseptal sheath, anchor delivery catheter, implant delivery catheter, and clip delivery catheter; and methods for transcatheter implantation of a coaptation element across a heart valve.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation application of U.S.application Ser. No. 16/220,322 filed Dec. 14, 2018, which is acontinuation application of U.S. application Ser. No. 14/313,975 filedJun. 24, 2014, which claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Application No. 61/895,647, filed on Oct. 25, 2013. Each ofthe foregoing applications of which are hereby incorporated by referencein their entireties. Any and all applications for which a foreign ordomestic priority claim is identified in the Application Data Sheet asfiled with the present application, are hereby incorporated by referencein their entirety under 37 CFR 1.57.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention generally provides improved medical devices,systems, and methods, typically for treatment of heart valve diseaseand/or for altering characteristics of one or more valves of the body.Embodiments of the invention include implants for treatment of mitralvalve regurgitation.

The human heart receives blood from the organs and tissues via theveins, pumps that blood through the lungs where the blood becomesenriched with oxygen, and propels the oxygenated blood out of the heartto the arteries so that the organ systems of the body can extract theoxygen for proper function. Deoxygenated blood flows back to the heartwhere it is once again pumped to the lungs.

The heart includes four chambers: the right atrium (RA), the rightventricle (RV), the left atrium (LA) and the left ventricle (LV). Thepumping action of the left and right sides of the heart occurs generallyin synchrony during the overall cardiac cycle.

The heart has four valves generally configured to selectively transmitblood flow in the correct direction during the cardiac cycle. The valvesthat separate the atria from the ventricles are referred to as theatrioventricular (or AV) valves. The AV valve between the left atriumand the left ventricle is the mitral valve. The AV valve between theright atrium and the right ventricle is the tricuspid valve. Thepulmonary valve directs blood flow to the pulmonary artery and thence tothe lungs; blood returns to the left atrium via the pulmonary veins. Theaortic valve directs flow through the aorta and thence to the periphery.There are normally no direct connections between the ventricles orbetween the atria.

The mechanical heartbeat is triggered by an electrical impulse whichspreads throughout the cardiac tissue. Opening and closing of heartvalves may occur primarily as a result of pressure differences betweenchambers, those pressures resulting from either passive filling orchamber contraction. For example, the opening and closing of the mitralvalve may occur as a result of the pressure differences between the leftatrium and the left ventricle.

At the beginning of ventricular filling (diastole) the aortic andpulmonary valves are closed to prevent back flow from the arteries intothe ventricles. Shortly thereafter, the AV valves open to allowunimpeded flow from the atria into the corresponding ventricles. Shortlyafter ventricular systole (i.e., ventricular emptying) begins, thetricuspid and mitral valves normally shut, forming a seal which preventsflow from the ventricles back into the corresponding atria.

Unfortunately, the AV valves may become damaged or may otherwise fail tofunction properly, resulting in improper closing. The AV valves arecomplex structures that generally include an annulus, leaflets, chordaeand a support structure. Each atrium interfaces with its valve via anatrial vestibule. The mitral valve has two leaflets; the analogousstructure of the tricuspid valve has three leaflets, and opposition orengagement of corresponding surfaces of leaflets against each otherhelps provide closure or sealing of the valve to prevent blood flowingin the wrong direction. Failure of the leaflets to seal duringventricular systole is known as malcoaptation, and may allow blood toflow backward through the valve (regurgitation). Heart valveregurgitation can have serious consequences to a patient, oftenresulting in cardiac failure, decreased blood flow, lower bloodpressure, and/or a diminished flow of oxygen to the tissues of the body.Mitral regurgitation can also cause blood to flow back from the leftatrium to the pulmonary veins, causing congestion. Severe valvularregurgitation, if untreated, can result in permanent disability ordeath.

Description of the Related Art

A variety of therapies have been applied for treatment of mitral valveregurgitation, and still other therapies may have been proposed but notyet actually used to treat patients. While several of the knowntherapies have been found to provide benefits for at least somepatients, still further options would be desirable. For example,pharmacologic agents (such as diuretics and vasodilators) can be usedwith patients having mild mitral valve regurgitation to help reduce theamount of blood flowing back into the left atrium. However, medicationscan suffer from lack of patient compliance. A significant number ofpatients may occasionally (or even regularly) fail to take medications,despite the potential seriousness of chronic and/or progressivelydeteriorating mitral valve regurgitation. Pharmacological therapies ofmitral valve regurgitation may also be inconvenient, are oftenineffective (especially as the condition worsens), and can be associatedwith significant side effects (such as low blood pressure).

A variety of surgical options have also been proposed and/or employedfor treatment of mitral valve regurgitation. For example, open-heartsurgery can replace or repair a dysfunctional mitral valve. Inannuloplasty ring repair, the posterior mitral annulus can be reduced insize along its circumference, optionally using sutures passed through amechanical surgical annuloplasty sewing ring to provide coaptation. Opensurgery might also seek to reshape the leaflets and/or otherwise modifythe support structure. Regardless, open mitral valve surgery isgenerally a very invasive treatment carried out with the patient undergeneral anesthesia while on a heart-lung machine and with the chest cutopen. Complications can be common, and in light of the morbidity (andpotentially mortality) of open-heart surgery, the timing becomes achallenge—sicker patients may be in greater need of the surgery, butless able to withstand the surgery. Successful open mitral valvesurgical outcomes can also be quite dependent on surgical skill andexperience.

Given the morbidity and mortality of open-heart surgery, innovators havesought less invasive surgical therapies. Procedures that are done withrobots or through endoscopes are often still quite invasive, and canalso be time consuming, expensive, and in at least some cases, quitedependent on the surgeon's skill. Imposing even less trauma on thesesometimes frail patients would be desirable, as would be providingtherapies that could be successfully implemented by a significant numberof physicians using widely distributed skills. Toward that end, a numberof purportedly less invasive technologies and approaches have beenproposed. These include devices which seek to re-shape the mitralannulus from within the coronary sinus; devices that attempt to reshapethe annulus by cinching either above to below the native annulus;devices to fuse the leaflets (imitating the Alfieri stitch); devices tore-shape the left ventricle, and the like.

Perhaps most widely known, a variety of mitral valve replacementimplants have been developed, with these implants generally replacing(or displacing) the native leaflets and relying on surgically implantedstructures to control the blood flow paths between the chambers of theheart. While these various approaches and tools have met with differinglevels of acceptance, none has yet gained widespread recognition as anideal therapy for most or all patients suffering from mitral valveregurgitation.

Because of the challenges and disadvantages of known minimally invasivemitral valve regurgitation therapies and implants, still furtheralternative treatments have been proposed. Some of the alternativeproposals have called for an implanted structure to remain within thevalve annulus throughout the heart beat cycle. One group of theseproposals includes a cylindrical balloon or the like to remain implantedon a tether or rigid rod extending between the atrium and the ventriclethrough the valve opening. Another group relies on an arcuate ringstructure or the like, often in combination with a buttress orstructural cross-member extending across the valve so as to anchor theimplant. Unfortunately, sealing between the native leaflets and the fullperimeter of a balloon or other coaxial body may prove challenging,while the significant contraction around the native valve annulus duringeach heart beat may result in significant fatigue failure issues duringlong-term implantation if a buttress or anchor interconnecting crossmember is allowed to flex. Moreover, the significant movement of thetissues of the valve may make accurate positioning of the implantchallenging regardless of whether the implant is rigid or flexible.

In light of the above, it would be desirable to provide improved medicaldevices, systems, and methods. It would be particularly desirable toprovide new techniques for treatment of mitral valve regurgitation andother heart valve diseases, and/or for altering characteristics of oneor more of the other valves of the body. The need remains for a devicewhich can directly enhance leaflet coaptation (rather than indirectlyvia annular or ventricular re-shaping) and which does not disruptleaflet anatomy via fusion or otherwise, but which can be deployedsimply and reliably, and without excessive cost or surgical time. Itwould be particularly beneficial if these new techniques could beimplemented using a less-invasive approach, without stopping the heartor relying on a heart-lung machine for deployment, and without relyingon exceptional skills of the surgeon to provide improved valve and/orheart function.

SUMMARY OF THE INVENTION

The invention generally provides improved medical devices, systems, andmethods. In some embodiments, the invention provides new implants,implant systems, and methods for treatment of mitral valve regurgitationand other valve diseases. In some embodiments, the implants comprise acoaptation assist body which remains within the blood flow path as thevalve moves back and forth between an open-valve configuration and aclosed valve configuration. The coaptation assist body may extendlaterally across some, most, or all of the width of the valve opening,allowing coaptation between at least one of the native leaflets and theimplant body. In some embodiments, also disclosed is an implant, whichcan be a cardiac implant, such as a coaptation assist body, cardiacpatch, replacement heart valve, annuloplasty ring, pacemaker, sensor, orother device. At least one ribbon (e.g., clip) can be configured toextend from the implant body. The ribbon can be made of a shape memorymaterial having a preformed shape with at least one curve. The ribboncan be movable from a first compressed configuration to a secondexpanded configuration. The ribbon can be configured to provide a force,such as a compressive force to clip to a body structure, such as anintracardiac structure. In some embodiments, the intracardiac structureis a single native valve leaflet, and the force is applied between afirst surface of the ribbon and a second surface of the ribbon opposedfrom the first surface of the ribbon. The compressive force can besufficient to secure the implant in the vicinity of the native valveannulus.

In some embodiments, an implant for treating mal-coaptation of a heartvalve is provided. The heart valve can have an annulus and first andsecond leaflets with an open configuration and a closed configuration.The implant can include a coaptation assist body having a firstcoaptation surface configured to be disposed to the posterior leaflet,an opposed second surface configured to be disposed toward the anteriorleaflet. The implant can include at least one ribbon configured toextend from the coaptation assist body. The ribbon can comprise a shapememory material having a preformed shape with at least one, two, or morediscrete curves. The ribbon can be movable from a first compressedconfiguration to a second expanded configuration. The ribbon can beconfigured to provide a compressive force on a native valve leafletbetween a first surface and a second surface opposed from the firstsurface of the ribbon. The compressive force can be sufficient to securethe implant, such as the coaptation assist body, in the vicinity of thenative valve annulus. The ribbon can be configured to provideventricular attachment of the implant. The ribbon can comprise a nitinolalloy. The ribbon can be self-expanding. The implant can include aplurality of ribbons. The ribbon can be configured to engage the leftventricle wall. The ribbon can be configured to engage the anterior orthe posterior leaflet. The ribbons can resist movement of the implant.The implant can include at least one eyelet configured to accept aportion of an anchor there through. The implant can include a clip andpledget configured to secure the anchor to the coaptation assist body.

In some embodiments, an implant for treating mal-coaptation of a heartvalve is provided. The heart valve can have an annulus and first andsecond leaflets with an open configuration and a closed configuration.The implant can include a coaptation assist body having a firstcoaptation surface configured to be disposed to the posterior leaflet,an opposed second surface configured to be disposed toward the anteriorleaflet. The implant can include a first anchor selectively deployableat a first target location. The implant can include a first rail coupledto the first anchor. The implant can include a second anchor selectivelydeployable, independently of the deployment of the first anchor, at asecond location of the heart. The implant can include a second railcoupled to the second anchor. The coaptation assist body can beconfigured to slide along the first rail and the second rail to theimplantation site. The coaptation assist body can be configured to slidealong the first rail and the second rail when collapsed to fit within adelivery catheter. The coaptation assist body can be configured to slidealong the first rail and the second rail when expanded upon exiting adelivery catheter. The first rail can be a suture. The second rail canbe a suture. The ventricular anchor can be unfolded and held in relationto the coaptation assist body when the coaptation assist body slidesalong the first rail and the second rail. The ventricular anchor cantraverse the mitral valve when the coaptation assist body slides alongthe first rail and the second rail. The implant can include a clip andpledget configured to secure the first anchor to the coaptation assistbody. The implant can include a clip and pledget configured to securethe second anchor to the coaptation assist body. The first rail can beconfigured to be removed once first anchor is secured to the coaptationassist body. The second rail can be configured to be removed once secondanchor is secured to the coaptation assist body.

In some embodiments, an implant for treating mal-coaptation of a heartvalve, comprises a coaptation assist body having a first coaptationsurface, an opposed second surface, each surface bounded by a firstlateral edge; a first anchor selectively deployable at a first targetlocation of the heart near the second leaflet on the annulus andcoupleable to the coaptation assist body near the superior edge; asecond anchor selectively deployable, independently of the deployment ofthe first anchor, at a second location of the heart in the ventriclesuch that the coaptation assist body, when coupled to both the firstanchor and the second anchor, extends from the first target locationacross the valve to the second target location; and wherein the secondanchor is a ventricular anchor capable of engaging a wall of the leftventricle.

In some embodiments, a method for treating mal-coaptation of a heartvalve in a patient, the heart valve having an annulus and first andsecond leaflets, the first and second leaflets each comprising aproximal surface, a distal surface, a coaptation edge and an annularedge; the annulus further defining a valve plane, the valve planeseparating an atrium proximally and a ventricle distally, the methodcomprises: selectively deploying a first anchor into heart tissue nearanterior and posterior fibrous trigones; selectively deploying a secondanchor near the left ventricle wall; coupling the first anchor and thesecond anchor to a coaptation assist body comprising a coaptationsurface and a leaflet surface such that the coaptation assist body issuspended across the valve plane from the atrium proximally to theventricle distally.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A-1F schematically illustrate some of the tissues of the heart andmitral valve, as described in the Background section and below, andwhich may interact with the implants and systems described herein.

FIG. 2A illustrates a simplified cross-section of a heart, schematicallyshowing mitral valve function during diastole. FIG. 2B illustrates asimplified cross-section of a heart, schematically showing mitral valvefunction during systole.

FIGS. 3A-3B illustrate a simplified cross-section of a heart,schematically showing mitral valve regurgitation during systole in thesetting of mal-coaptation of the mitral valve leaflets.

FIG. 4A illustrates a stylized cross section of a heart, showing mitralvalve mal-coaptation in the settings of functional mitral valveregurgitation. FIG. 4B illustrates a stylized cross section of a heart,showing mitral valve mal-coaptation in the settings of degenerativemitral valve regurgitation.

FIG. 5A schematically illustrates an embodiment of the coaptationassistance device; FIG. 5B schematically illustrates a top view of thecoaptation assistance device of FIG. 5A; FIGS. 5C-5D schematicallyillustrates lateral views of the coaptation assistance device of FIG.5A.

FIG. 6A schematically illustrates the coaptation assistance device ofFIG. 5A in its collapsed state; FIG. 6B schematically illustrates thecoaptation assistance device of FIG. 5A as it is deployed; FIG. 6Cschematically illustrates the coaptation assistance device of FIG. 5Adeployed with connecting struts; FIG. 6D schematically illustrates thecoaptation assistance device of FIG. 5A deployed.

FIG. 7 schematically illustrates an embodiment of the transseptalsheath.

FIG. 8 illustrates an embodiment of the anchor delivery catheter.

FIG. 9A schematically illustrates an embodiment of an implant deliverycatheter and the transseptal sheath of FIG. 7; FIG. 9B schematicallyillustrates the attachment of the coaptation assistance device to theimplant delivery catheter; FIG. 9C schematically illustrates theadvancement of the coaptation assistance device over two rails.

FIG. 10 schematically illustrates an embodiment of a clip deliverycatheter.

FIG. 11A schematically illustrates the insertion of the transseptalsheath; FIG. 11B schematically illustrates the engagement of the firsttrigonal anchor and the placement of the anchors; FIG. 11C schematicallyillustrates the coaptation assistance device deployed and advanced overtwo rails; FIG. 11D schematically illustrates the engagement of aventricular anchor; FIG. 11E schematically illustrates the engagement ofa clip and a pledget; FIG. 11F schematically illustrates the coaptationassistance device deployed across the mitral valve.

FIG. 12A schematically illustrates a clip and a pledget initially loadedon a hypotube of the clip delivery catheter of FIG. 10; FIG. 12Bschematically illustrates the engagement of the clip with an anchorsuture; FIG. 12C schematically illustrates the hypotube crimped over aguide suture; FIG. 12D schematically illustrates the cutting of theguide suture.

FIG. 13 schematically illustrates an embodiment of the coaptationassistance device.

FIG. 14A schematically illustrates the insertion of the transseptalcatheter;

FIG. 14B schematically illustrates the collapsed coaptation assistancedevice of FIG. 13 and the placement of the anchors; FIG. 14Cschematically illustrates the coaptation assistance device deployed andadvanced over guidewires; FIG. 14D schematically illustrates theengagement of a ventricular anchor.

FIG. 15 schematically illustrates an embodiment of the coaptationassistance device.

FIG. 16 schematically illustrates an embodiment of the coaptationassistance device.

FIG. 17A schematically illustrates an embodiment of the coaptationassistance device; FIG. 17B schematically illustrates a lateral view ofan embodiment of the coaptation assistance device.

FIG. 18A schematically illustrates an embodiment of the deliverycatheter;

FIG. 18B schematically illustrates the coaptation assistance device ofFIG. 17A deployed across the mitral valve; FIG. 18C schematicallyillustrates the top view of the coaptation assistance device deployedacross the mitral valve.

DETAILED DESCRIPTION

Disclosed herein are improved medical devices, systems, and methods,often for treatment of mitral valve regurgitation and other valvediseases including tricuspid regurgitation. While the description thatfollows includes reference to the anterior leaflet in a valve with twoleaflets such as the mitral valve, it is understand that “anteriorleaflet” could refer to one or more leaflets in a valve with multipleleaflets. For example, the aortic valve or tricuspid valve typically has3 leaflets so the “anterior” could refer to one or two of the medial,lateral, and posterior leaflets. The implants described herein willgenerally include a coaptation assist body (sometimes referred to hereinas a valve body) which is generally along the blood flow path as theleaflets of the valve move back and forth between an open-valveconfiguration (with the anterior leaflet separated from valve body) anda closed-valve configuration (with the anterior leaflet engaging opposedsurfaces of the valve body). The valve body will be disposed between thenative leaflets to close the gap caused by mal-coaptation of the nativeleaflets by providing a surface for at least one of the native leafletsto coapt against, while effectively replacing second native leaflet inthe area of the valve which it would occlude during systole, were itfunctioning normally. The gaps may be lateral (such as may be caused bya dilated left ventricle and/or mitral valve annulus) and/or axial (suchas where one leaflet prolapses or is pushed by fluid pressure beyond theannulus when the valve should close).

Among other uses, the coaptation assistance devices, implants, andmethods described herein may be configured for treating functionaland/or degenerative mitral valve regurgitation (MR) by creating anartificial coaptation zone within which at least one of the nativemitral valve leaflets can seal. The structures and methods herein willlargely be tailored to this application, though alternative embodimentsmight be configured for use in other valves of the heart and/or body,including the tricuspid valve, valves of the peripheral vasculature, theinferior vena cava, or the like.

Referring to FIGS. 1A-1D, the four chambers of the heart are shown, theleft atrium 10, right atrium 12, left ventricle 14, and right ventricle16. The mitral valve 20 is disposed between the left atrium 10 and leftventricle 14. Also shown are the tricuspid valve 22 which separates theright atrium 12 and right ventricle 16, the aortic valve 24, and thepulmonary valve 26. The mitral valve 20 is composed of two leaflets, theanterior leaflet 30 and posterior leaflet 32. In a healthy heart, theedges of the two leaflets oppose during systole at the coaptation zone34.

The fibrous annulus 36, part of the cardiac skeleton, providesattachment for the two leaflets 30, 32 of the mitral valve 20, referredto as the anterior leaflet 30 and the posterior leaflet 32. The leaflets30, 32 are axially supported by attachment to the chordae tendinae 40.The chordae 40, in turn, attach to one or both of the papillary muscles42, 44 of the left ventricle 14. In a healthy heart, the chordae 40support structures tether the mitral valve leaflets 30, 32, allowing theleaflets 30, 32 to open easily during diastole but to resist the highpressure developed during ventricular systole. In addition to thetethering effect of the support structure, the shape and tissueconsistency of the leaflets 30, 32 helps promote an effective seal orcoaptation. The leading edges of the anterior and posterior leaflet cometogether along a funnel-shaped zone of coaptation 34, with a lateralcross-section 46 of the three-dimensional coaptation zone (CZ) beingshown schematically in FIG. 1E.

The anterior and posterior mitral leaflets 30, 32 are dissimilarlyshaped. The anterior leaflet 30 is more firmly attached to the annulusoverlying the central fibrous body (cardiac skeleton), and is somewhatstiffer than the posterior leaflet 32, which is attached to the moremobile posterior mitral annulus. Approximately 80 percent of the closingarea is the anterior leaflet 30. Adjacent to the commissures 50, 52, onor anterior to the annulus 36, lie the left (lateral) 56 and right(septal) 60 fibrous trigones which are formed where the mitral annulusis fused with the base of the non-coronary cusp of the aorta (FIG. 1F).The fibrous trigones 56, 60 form the septal and lateral extents of thecentral fibrous body 62. The fibrous trigones 56, 60 may have anadvantage, in some embodiments, as providing a firm zone for stableengagement with one or more annular or atrial anchors. The coaptationzone 34 between the leaflets 30, 32 is not a simple line, but rather acurved funnel-shaped surface interface. The first 50 (lateral or left)and second 52 (septal or right) commissures are where the anteriorleaflet 30 meets the posterior leaflet 32 at the annulus 36. As seenmost clearly in the axial views from the atrium of FIGS. 1C, 1D, and 1F,an axial cross-section of the coaptation zone 34 generally shows thecurved line CL that is separated from a centroid of the annulus CA aswell as from the opening through the valve during diastole CO. Inaddition, the leaflet edges are scalloped, more so for the posteriorleaflet 32 versus the anterior leaflet 30. Mal-coaptation can occurbetween one or more of these A-P (anterior-posterior) segment pairsA1/P1, A2/P2, and A3/P3, so that mal-coaptation characteristics may varyalong the curve of the coaptation zone 34.

Referring now to FIG. 2A, a properly functioning mitral valve 20 of aheart is open during diastole to allow blood to flow along a flow pathFP from the left atrium 10 toward the left ventricle 14 and thereby fillthe left ventricle 14. As shown in FIG. 2B, the functioning mitral valve20 closes and effectively seals the left ventricle 14 from the leftatrium 10 during systole, first passively then actively by increase inventricular pressure, thereby allowing contraction of the heart tissuesurrounding the left ventricle 14 to advance blood throughout thevasculature.

Referring to FIGS. 3A-3B and 4A-4B, there are several conditions ordisease states in which the leaflet edges of the mitral valve 20 fail tooppose sufficiently and thereby allow blood to regurgitate in systolefrom the left ventricle 14 into the left atrium 10. Regardless of thespecific etiology of a particular patient, failure of the leaflets toseal during ventricular systole is known as mal-coaptation and givesrise to mitral regurgitation.

Generally, mal-coaptation can result from either excessive tethering bythe support structures of one or both leaflets 30, 32, or from excessivestretching or tearing of the support structures. Other, less commoncauses include infection of the heart valve, congenital abnormalities,and trauma. Valve malfunction can result from the chordae tendinae 40becoming stretched, known as mitral valve prolapse, and in some casestearing of the chordae 40 or papillary muscle 44, known as a flailleaflet 64, as shown in FIG. 3A. Or if the leaflet tissue itself isredundant, the valves may prolapse so that the level of coaptationoccurs higher into the left atrium 10, opening the valve 20 higher inthe left atrium 10 during ventricular systole 66. Either one of theleaflets 30, 32 can undergo prolapse or become flail. This condition issometimes known as degenerative mitral valve regurgitation.

In excessive tethering, as shown in FIG. 3B, the leaflets 30, 32 of anormally structured valve may not function properly because ofenlargement of or shape change in the valve annulus 36: so-calledannular dilation 70. Such functional mitral regurgitation generallyresults from heart muscle failure and concomitant ventricular dilation.And the excessive volume load resulting from functional mitralregurgitation can itself exacerbate heart failure, ventricular andannular dilation, thus worsening mitral regurgitation.

FIG. 4A-4B illustrate the backflow BF of blood during systole infunctional mitral valve regurgitation (FIG. 4A) and degenerative mitralvalve regurgitation (FIG. 4B). The increased size of the annulus 36 inFIG. 4A, coupled with increased tethering due to hypertrophy of the leftventricle 14 and papillary muscles 42, 44, prevents the anterior leaflet30 and posterior leaflet 32 from opposing, thereby preventingcoaptation. In FIG. 4B, the tearing of the chordae 40 causes prolapse ofthe posterior leaflet 32 upward into the left atrium 10, which preventsopposition against the anterior leaflet 30. In either situation, theresult is backflow of blood into the left atrium 10, which decreases theeffectiveness of left ventricle compression.

FIGS. 5A-5D show four views of an embodiment of a coaptation assistancedevice 80 which comprises a body 82. The body 82 comprises a firstsurface 84 disposed toward a mal-coapting native leaflet, in theinstance of a mitral valve 20, the posterior leaflet 32 and a secondsurface 86 which may be disposed toward the anterior leaflet 30. Thefirst and second surfaces 84, 86 can be considered a coaptation surface.The superior edge 90 of the body 82 may be curved to match the generalshape of the annulus 36 or adjoining atrial wall. The coaptationassistance device 80 can comprise a frame 88 configured to providestructural support to the coaptation assistance device 80. In someembodiments, the frame 88 is collapsible to fit within a deliverycatheter, as described herein.

The coaptation assistance device 80 may include one or a plurality ofanchors to stabilize the device, such as atrial anchors and/orventricular anchors, with the anchors optionally providing redundantfixation. As shown in FIG. 5A, the implant has lateral commissuralanchors 92 which may help maintain the shape and position of thecoaptation assistance device 80 once deployed in the heart. In someembodiments, the lateral commissural anchors 92 are placed under theleaflets 30, 32 at the site of commissures 50, 52. The coaptationassistance device 80 can also have a posterior anchor 94. In someembodiments, the posterior anchor 94 engages the area under theposterior leaflet 32. As shown in FIG. 5A, the commissural anchors 92and the posterior anchors 94 can each comprise ribbons 98 that have abias such that they can exert a force, and rest against the tissue ofthe heart, such as the ventricle. The ribbons 98 function as anchors andresist movement of the coaptation assistance device 80, and can do sowithout penetrating the myocardium in some embodiments. The positioningof the ribbons 98 against features of the anatomy may provide stabilityof the coaptation assistance device 80. The ribbons 98 may comprisebio-inert materials such as, for example, Platinum/Ir, a Nitinol alloy,and/or stainless steel. In some embodiments, the ribbons 98 compriseNiTi. In some embodiments, the ribbons 98 have a pre-determined curve.The material selection combined with the selected shape provides anchors92, 94 that are spring loaded. The ribbons 98 extend in a direction,such as downward, from the frame 88. The ribbons 98 curve and thenextend upward, forming a generally U-shaped configuration. The ribbons98 comprise a rounded top surface configured to abut tissue. Othershapes for the ribbons 98 are contemplated. As disclosed herein, thecoaptation assistance device 80 is collapsed inside the deliverycatheter 100 as shown in FIG. 6A. The spring loaded ribbons 98 arecapable of being collapsed within the delivery catheter. Upon exitingthe catheter, the spring loaded ribbons 98 rapidly expand into thepreformed shape. In some embodiments, the ribbons 98 are provided forventricular attachment. The ribbons 98 allow for very rapid attachmentof the coaptation assistance device 80 to the tissue, since the ribbons98 do not rely on annular sutures and do not require tying knots in someembodiments. The deployment of the ribbons 98 can be faster thanengaging a helical anchor, for instance.

In some embodiments, the coaptation assistance device 80 includes anannular anchor 96. The annular anchor 96 can be, in some embodiments, aradially expandable stent-like structure, as shown in FIG. 5A. Like thecommissural anchors 92, the annular anchor 96 can be collapsed to fitinside a catheter, described herein. In some embodiments, the annularanchor 96 can be delivered to the site of the mitral valve 20. In someembodiments, the annular anchor 92 is intended for placement in themitral annulus 36. The annular anchor 96 may include a plurality ofbarbs for acute fixation to the surrounding tissue. In some embodiments,the annular anchor 96 may be simply held in place via radial forces. Theannular anchor 96, if it is included, may be covered with biocompatiblematerials such as ePTFE or Dacron to promote endothelialization and,optionally, chronic tissue in-growth or encapsulation of the annularanchor for additional stability.

In other embodiments, the atrial anchors may comprise a plurality ofhelixes, clips, harpoon or barb-shaped anchors, or the like, appropriatefor screwing or engaging into the annulus 36 of the mitral valve 20,tissues of the ventricle 14, other tissues of the atrium 10, or othertissue. The body 82 can include one or more features such as eyelets ortethers to couple with the atrial anchors.

The coaptation assistance device 80 has a geometry which permits it totraverse the mitral valve 20 between attachment sites in the left atrium10 and left ventricle 14, to provide a coaptation surface 86 for theanterior leaflet 30 to coapt against, and attach to the left atrium 10or annulus 36 such that it effectively seals off the posterior leaflet32. In the instance that the posterior leaflet 32 is or has beenremoved, the coaptation assistance device 80 replaces the posteriorleaflet 32.

Different sized coaptation assistance device 80, particularly thedifferent sized bodies 82, can be placed such that the native anteriorleaflet 30 opposes the coaptation surface 86 at the appropriatelyestablished coaptation point, blocking flow of blood during contractionof the left ventricle 14. In order to accomplish this, a variety ofsizes of coaptation assistance device 80 are provided, with differingdimensions configured to fit varying anatomies. As seen in the top viewof FIG. 5B, there is a dimension A which is an inter-commissuraldistance. This distance may be, for example, within a range of about 20mm to about 80 mm, and in one embodiment about 40 mm. There is adimension B which is an anterior-posterior diameter. This diameter maybe, for example, within a range of about 20 mm to about 60 mm, and inone embodiment about 35 mm. There is a dimension C which is theanterior-posterior projection. This dimension may be within a range of,e.g., about 10 mm to about 30 mm depending on the mitral valveregurgitation (MR). For degenerative MR, this dimension may be, e.g.,within a range of about 10 mm to about 20 mm. For functional MR, thisdimension may be, e.g., within a range of about 20 mm to about 30 mm. Asshown in FIG. 5D, there is a dimension D which is the coaptationassistance device 80 height. This dimension may be, e.g., within a rangeof about 20 mm to about 50 mm, and in one embodiment about 25 mm.

Turning now to FIGS. 6A-6D, an embodiment of the coaptation assistancedevice 80 is shown. It can be seen that in some embodiments, thecoaptation assistance device 80 is collapsed inside the deliverycatheter 100. The stent-like structure of the frame 88 of the coaptationassistance device 80 including the structure of the annular anchor 96and commissural anchors 92 allows the coaptation assistance device 80 tobe collapsed.

In the embodiment shown in FIGS. 6B-6C, a number of struts 102 maycouple to the coaptation assistance device 80. The struts 102 mayconnect to the coaptation assistance device 80 at any number oflocations, e.g., superior edge 90, annular anchor 94, commissuralanchors 92, to a ventricular hub described herein. The struts 102 couplethe coaptation assistance device 80 to the catheter 100 and/or implantintroducer 104. Each strut 102 may comprise a single longitudinalelement or be doubled over to comprise two or more strands. A singlestrut 102 may be comprised of a strand of Nitinol wire, suture, or othermaterial which loops toward the superior aspect of the implant. Thisloop area may provide reinforcement around an interruption in thecovering material. In some embodiments, the struts 102 could includeclips, jaws, adhesive, or another mechanism to form a releasableattachment between the struts 102 and the coaptation assistance device80. The struts 102 may be, as shown, placed such that they arerelatively evenly spaced, or may be concentrated toward the center orlateral edges of the coaptation assistance device 80. The struts 102 maybe coupleable with the anchors 92, 94, 96 which may be deployed intovarious locations including the mitral annulus 36, left atrium 10, leftauricle, one of the fibrous trigones 56, or the left ventricle 14.

As shown in FIGS. 6A-6D, the body 82 of the coaptation assistance device80 can be delivered by a delivery catheter 100 and may be capable ofexpanding from a smaller profile to a larger profile to dimensionsappropriate for placement in between the valve's native leaflets 30, 32.The coaptation assistance device 80 is expanded as it is exposed fromthe tip of the delivery catheter 100. In some embodiments, the deliverycatheter 100 is pulled back to expose the coaptation assistance device80 as shown by the arrow in FIG. 6B. The exposed coaptation assistancedevice 80 is detached from the delivery catheter 100 as shown in FIG.6D, for instance by releasing the struts 102.

Turning now toward implantation, a coaptation assistance device 180 maybe implanted through a minimally invasive or transcatheter techniqueutilizing a delivery system 106. The coaptation assistance device 180can be substantially similar to the coaptation assistance device 80described herein. The delivery system 106 can include one or more of thefollowing devices: a transseptal sheath 110 shown in FIG. 7, an anchordelivery catheter 112 shown in FIG. 8, an implant delivery catheter 114shown in FIGS. 9A-9B, and a clip delivery catheter 116 shown in FIG. 10.As illustrated in FIG. 7, the delivery system 106 may include atransseptal sheath 110 having a shaft 120 that may be made of apolymeric or other material. In some embodiments, the shaft 120 is abraid or coil reinforced polymer shaft. In some embodiments, the shaft120 has multiple durometers, such as a first smaller durometer at afirst location and a second larger durometer at a second location distalor proximal to the first location. In some embodiments, the transseptalsheath 110 is pre-shaped. The shaft 120 can include at least one throughlumen (e.g., two, or more through lumens). In some embodiments, thetransseptal sheath 110 comprises an actively deflectable tip 122 tofacilitate navigation into the left ventricle 14. The deflectable tip122 can be controlled by various mechanisms, for instance via pullwiresoperably attached to the deflectable tip 122 and connected to a proximalcontrol.

The transseptal sheath 110 may include a seal 124 to accommodate variousinstruments and guidewires inserted therein. The seal can accommodatediameters including the outer diameter of the anchor delivery catheter112, the implant delivery catheter 114, and the clip delivery catheter116. In some embodiments, the accommodated diameters can be up to 22 Fr.The transseptal sheath 110 may include lined inner diameter 126. Thelined inner diameter 126 may be within a range of about 10 to about 22Fr, and in one embodiment preferably 16 Fr. The transseptal sheath 110has sufficient length over a section 130 to span from the access point(e.g., outside the body) to the tip of the left ventricle 14. The accesspoint may be via groin/femoral access. This length may be, e.g., withina range of about 80 cm to about 120 cm, and in one embodiment about 100cm. The transseptal sheath 110 may include atraumatic tip 132. The tip132 may include a marker band 134 for visualization. The transseptalsheath 110 may include flush port 136 operably connected to the centrallumen of shaft 120 at a proximal hub 140 as illustrated. The system mayfurther include additional ports, including flush, irrigation and/oraspiration ports to remove fluid or air from the system and allowinjection of fluids such as saline or contrast media to the site ofimplantation.

Referring now to FIG. 8, aspects of the anchor delivery catheter 112 areillustrated. FIG. 8 shows an embodiment of the anchor delivery catheter112. The anchor delivery catheter 112 may include a shaft 142 made of amaterial such as a polymer. In some embodiments, the shaft 142 is abraid or coil reinforced polymer shaft. In some embodiments, the shaft142 has multiple durometers, such as a first smaller durometer at afirst location and a second larger durometer at a second location distalor proximal to the first location. The anchor delivery catheter 112 hassufficient length over a section 162 to span from the access point(e.g., outside the body) and through the transseptal sheath 110. Thislength may be, e.g., within a range of about 90 cm to about 130 cm, andin one embodiment about 110 cm. In other embodiments, the anchordelivery catheter 112 comprises an actively deflectable tip 144 tofacilitate navigation of the anchors to the anchoring sites. The anchordelivery catheter 112 is configured to deploy an anchor 146.

The anchor delivery catheter 112 may include a drive shaft 150. Thedrive shaft 150 is configured to couple with a drive continuation 152 toallow transmission of torque to the anchor 146. In some embodiments, thedrive shaft 150 is flexible. In some embodiments, the drive shaft 150 iscapable of being advanced or retracted. The anchor delivery catheter 112may include a handle 154. The handle 154 may include a knob 156 toenable simple manipulation of the torque or position of the anchor 146.The knob is internally connected to the drive shaft 150 thereby allowingtransmission of torque to the anchor 146 when the knob 156 is rotated.

The anchor 146 has an outer diameter which may be within a range ofabout 1 to about 6 mm, and in one embodiment preferably 4 mm. The anchor146 may be helical with a pitch within a range of about 0.4 to about 1.5mm, and in one embodiment preferably 0.8 mm. The anchor 146 in someembodiments has a wire diameter which may be within a range of about0.25 to about 0.75 mm, and in one embodiment preferably 0.5 mm. Theanchor 146 may be coupled to the drive continuation 152. As shown, thedrive continuation 152 can be a square continuation of the anchor helix.However, the drive continuation 152 may be of any shape, such astriangular or hexagonal, capable of transmitting the torque imparted bythe drive shaft 150. The anchor 146 can include anchor suture 158. Theanchor delivery catheter 112 may include one or more rails 160 (e.g.,sutures, guidewires) attached to the proximal end of anchor 146 and/orthe anchor suture 158. For the anchor 146 shown in FIG. 8, such as thetrigonal anchor, the rails 160 (e.g., sutures, guidewires) facilitatesubsequent proper placement of the coaptation assistance device 180. Forsome method, the rails 160 are cut after anchor placement.

Referring now to FIG. 9A, aspects of the implant delivery catheter 114are illustrated. The implant delivery catheter 114 can be inserted intothe transseptal sheath 110 shown. The seal 124 is sized to accommodatethe implant delivery catheter 114. The transseptal sheath 110 allows theintroduction of the implant delivery catheter 114 through a lumen of theshaft 120 and into the left atrium 10. The transseptal sheath 110 mayinclude a variable stiffness outer shaft 120 with at least one lumen,the lumen sized to allow insertion of the implant delivery catheter 114and/or coaptation assistance device 180 through the lumen. Thedeflectable tip 122 and/or a deflectable portion of the shaft 120 mayfacilitate alignment of the coaptation assistance device 180 with thevalve leaflets 30, 32.

The implant delivery catheter 114 comprises a shaft 164. The shaft 164can be a variable stiffness shaft, with the stiffness varying along adimension, for instance along the length. The shaft 164 can include atleast one through lumen (e.g., two, or more through lumens). The shaft164 can be include a deflectable tip 166 configured for deflecting alongat least a distal section. The deflectable tip 166 can be controlled byvarious mechanisms, for instance via pullwires operably attached to thedeflectable tip 166 and connected to a proximal control.

The delivery catheter may further include an implant introducer 170. Theimplant introducer 170 can be sized to pass through the shaft 164 of theimplant delivery catheter 114. The implant introducer 170 can include aslot 172. The implant delivery catheter 114 may further include a handle174 to manipulate the implant delivery catheter 114 within thetransseptal sheath 110 and/or body of the patient. The handle 174 mayinclude a knob 176 to enable simple manipulation of the position of thecoaptation assistance device 180. The knob 176 is internally connectedto the implant introducer 170 thereby allowing transmission of movementto the implant introducer 170 when the knob 176 is manipulated. In someembodiments, the knob 176 can manipulate the docking and undocking ofthe coaptation assistance device 180 with the implant delivery catheter114. The handle 174 may further include one or more ports 182, such as aflush, irrigation and/or aspiration port to remove the air from thesystem and allow injection of fluids such as saline or contrast media tothe site of implantation.

As shown in FIG. 9B, the coaptation assistance device 180 is insertedinto the implant delivery catheter 114. The coaptation assistance device180 is shown in the top view of FIG. 9B. In some embodiments, thecoaptation assistance device 180 is unfolded in the direction of thearrows as shown in the middle view of FIG. 9B. The coaptation assistancedevice 180 can be coupled to the implant introducer 170. In someembodiments, a portion of the coaptation assistance device 180 is heldwithin the slot 172. In some embodiments, a portion of the coaptationassistance device 180 folds around the deflectable tip 166 of theimplant delivery catheter 114 in the direction of the arrows shown inthe bottom view of FIG. 9B. The coaptation assistance device 180 can becoupled to the implant introducer 170 and the deflectable tip 166 of theimplant delivery catheter 114. As shown in FIG. 9C, the attachedcoaptation assistance device 180 can slide along (e.g., engage) one ormore rails 184 (e.g., two rails 184), which may be rails 160 coupled toanchor 146. The rails 184 can extend through transseptal sheath 110 fromthe anchor 146 to the coaptation assistance device 180. The coaptationassistance device 180 can advance over two rails as shown in FIG. 9C. Insome embodiments, the rails 184 extend through eyelets or otherapertures of the coaptation assistance device 180. The rails 184 canextend through (e.g., be pulled through) the implant delivery catheter114. The rails 184 can help guide the coaptation assistance device 180toward the implantation site and/or toward the anchor 146. The rails 184in some embodiments are flexible guidewires and/or sutures. In someembodiments, the rails 184 are pulled in the direction of the arrows toadvance the coaptation assistance device 180 and/or implant deliverycatheter 114 through the transseptal sheath 110 In some embodiments,systems that include a plurality of rails 160, such as two rails 160 forexample advantageously allows for more controlled and symmetricdeployment of the coaptation assistance device.

Referring now to FIG. 10, aspects of the clip delivery catheter 116 areillustrated. The clip delivery catheter 116 comprises a shaft 186. Theshaft 186 can be a variable stiffness shaft, with the stiffness varyingalong a dimension, for instance along the length. The shaft 186 mayinclude a polymer shaft. In some embodiments, the shaft 186 is a braidor coil reinforced polymer shaft. In some embodiments, the shaft 186 hasmultiple durometers. The shaft 186 can include at least one throughlumen (e.g., two, or more through lumens). In some embodiments, theshaft 186 comprises an actively deflectable tip 190 to facilitatenavigation of various clips 192 and/or pledgets 194 to the anchoringsites. The clips 192 and pledgets 194 may be comprised of any suitablematerial, such as suture, flexible material, Nitinol, metal, or plastic.In one embodiment, the preferred material is Nitinol. The deflectabletip 190 can be configured for deflecting along at least a distalsection. The deflectable tip 190 can be controlled by variousmechanisms, for instance via pullwires operably attached to thedeflectable tip 190 and connected to a proximal control.

The clip delivery catheter 116 has sufficient length to fully passthrough the transseptal sheath 110 with additional length provided fortip deflection. This distance may be within a range of, e.g., about 90cm to about 130 cm, and in one embodiment about 110 cm. The deliverycatheter may further include a hypotube 196. The implant hypotube 196can be sized to pass through the shaft 186 of the clip delivery catheter116. The clip delivery catheter 116 may further include a handle 200 tomanipulate the clip delivery catheter 116 within the transseptal sheath110 and/or body of the patient to steer the hypotube 196 of the clipdelivery catheter. The handle 200 may also deploy the clip 192 and/orpledget 194 to the intended site. The handle 200 may further include oneor more ports 202, such as a flush, irrigation and/or aspiration port toremove the air from the system and allow injection of fluids such assaline or contrast media to the site of implantation.

The hypotube 196 or other elongate member extends through the clip 192and/or the pledget 194. In some embodiments, the clip 192 and/or thepledget 194 are initially loaded on the hypotube 196, as shown. In someembodiments, a second hypotube 204 coaxial with and having a largerdiameter than the hypotube 196 is used to push the clip 192 and/or thepledget 194 from the hypotube 196. In some embodiments, the deflectabletip 190 having a larger diameter than the hypotube 196 is used to pushthe clip 192 and/or the pledget 194 from the hypotube 196. Othermechanism can be used to push the clip 192 and/or the pledget 194 (e.g.,pusher wire, jaws).

The clip delivery catheter 116 may include pledget 194. The pledget 194may be of generally circular shape as shown, or may be square orrectangular, elliptical, or any other desired form. The pledget 194 maybe comprised of any one of a number of suitable materials known to thoseof skill in the art. In some instances it may be advantageous to use amaterial which promotes tissue ingrowth, enhancing the connection of thecoaptation assist device 180 to the patient's tissue. In otherembodiments, a material which inhibits or is inert with respect totissue ingrowth may be preferred, such as ePTFE, VTFE, PTFE (polytetrafluoroethylene), Teflon, polypropylene, polyester, polyethyleneterephthalate, or any suitable material. In some embodiments, a coatingmay be placed on the pledget 194 to inhibit or encourage tissueingrowth. One or more anchors 146 may penetrate the material of thepledget 194 at a suitable position, securing the pledget 194 tounderlying cardiac tissue. Thus, in some embodiments, the pledget 194may comprise an easily punctured material, such as structural mesh,felt, or webbing.

The clip delivery catheter 116 may include clip 192. In one embodiment,the clip 192 is made from twisted strands of a metal or alloy, e.g.,NiTi 2-30 to form a cable. In some embodiments, eight strands aretwisted to form clip 192. In one embodiment, the strand diameters arewithin a range of about 0.01 to about 0.010 inches, and in oneembodiment about 0.006 inches.

Referring now to FIGS. 11A-11F, the implantation steps of one embodimentof the method is shown. As shown in FIG. 11A, a transseptal method fortreatment of MR will often include gaining access to the left atrium 10via a transseptal sheath 110. Access to the femoral vein may beobtained, for example, using the Seldinger technique. From the femoralvein, access can then be obtained via the right atrium 12 to the leftatrium 10 by a transseptal procedure. A variety of conventionaltransseptal access techniques and structures may be employed, so thatthe various imaging, guidewire advancement, septal penetration, andcontrast injection or other positioning verification steps need not bedetailed herein.

Transseptal sheaths, such as the transseptal sheath 110 and/or othertransseptal sheaths, can have an elongate outer sheath body of the shaft120 extending between a proximal handle 140 to a distal end, with thehandle 140 having an actuator (not shown) for steering a distal segmentand/or deflectable tip 122 of the shaft 120 similar to that describedabove. A distal electrode and/or marker 134 near the distal end ofsheath body can help position the sheath within the left atrium. In someembodiments, an appropriately sized deflectable transseptal sheath 110without steering capability may be guided into position in the leftatrium 10 by a steerable transseptal sheath 110 or may be advanced intothe left atrium 10 without use of a steerable transseptal sheath 110.Alternatively, deployment may proceed through a lumen of the steerablesheath. Regardless, in some embodiments an outer access sheath willpreferably be positioned so as to provide access to the left atrium LAvia a sheath lumen.

Referring now to FIG. 11B, the anchor delivery catheter 112 may beadvanced through the outer transseptal sheath 110 and into the leftatrium 10. The distal end and/or the deflectable tip 144 of the anchordelivery catheter 112 moves within the left atrium 10 by manipulatingthe proximal handle 154 and by articulating the actuator of the handle(not shown) so as to selectively bend the distal end and/or thedeflectable tip 144 of the anchor delivery catheter 112, bringing thedistal end of the anchor delivery catheter 112 into alignment and/orengagement with candidate locations for deployment of an anchor 146. Theanchor delivery catheter 112 can be aligned optionally under guidance of2D or 3D intracardiac, transthoracic, and/or transesophageal ultrasoundimaging, Doppler flow characteristics, fluoroscopic or X-ray imaging, oranother imaging modality.

In some embodiments, an electrode (not shown) at the distal end of theanchor delivery catheter 112 optionally senses electrogram signals andtransmits them to an electrogram system EG so as to help determine ifthe candidate site is suitable, such as by determining that theelectrogram signals include a mix of atrial and ventricular componentswithin a desired range (such as within an acceptable threshold of 1:2).Contrast agent or saline may be introduced through the anchor deliverycatheter 112.

As shown in FIG. 11B, the anchor 146, for instance a first trigonalanchor, is delivered and engaged with the implantation site. Anotheranchor, for instance a second trigonal anchor is delivered and engagedwith another implantation site. The locations of the anchors 146 areshown in relationship to the anterior leaflet 30 and the posteriorleaflet 32 as shown in the smaller snapshot. As shown in FIG. 11C, insome embodiments, each anchor 146 comprises at least one rail 160 (e.g.,suture, guidewire) such that the coaptation assistance device 180 can beadvance over the rail 160. The coaptation assistance device 180 isadvanced over one or more rails 160 (e.g., two rails) as shown by thearrows in FIG. 11C. In this way, the rails 160 facilitate placement ofthe coaptation assistance device 180. The coaptation assistance device180 is advanced over the posterior leaflet 32, as shown.

As shown in FIG. 11D, the coaptation assistance device 180 is extendedthrough the mitral valve 20 into the left ventricle 14. In someembodiments, the coaptation assistance device 180 may have a ventricularanchor 208 (e.g., ribbon such as the ribbons described herein or otherventricular anchor) that is expanded and engaged to attach thecoaptation assistance device 180. After placement of the coaptationassistance device 180 the coaptation assistance device 180 can be lockedon the anchors 146 (such as trigonal anchors) by one or more clips 192and/or one or more pledgets 194, as shown in FIG. 11E. After thecoaptation assistance device 180 is deployed and/or locked on theanchors 146, the delivery system 106 is removed, as shown in FIG. 11F.

The aforementioned method can be performed by a physician. In oneembodiment, a manufacturer can provides one, some or all of thefollowing: coaptation assistance devices, for instance coaptationassistance device 180, transseptal sheath 110, anchor delivery catheter112, implant delivery catheter 114, and clip delivery catheter 116. Insome embodiments, the manufacturer provides a kit containing some or allof the devices previously described.

In some embodiments, the manufacturer provides instructions for use ofthe system including one or more of the following steps, or any steppreviously described in the drawings. The steps may include: gainingaccess to the left atrium 10 via the transseptal sheath 110; gainingaccess to the femoral vein via the Seldinger technique; gaining accessvia the right atrium 12 to the left atrium 10 by a transseptalprocedure, utilizing a variety of conventional transseptal accesstechniques and structures. The steps may include: positioning thetransseptal sheath 110 within the left atrium 10; deploying the anchordelivery catheter 112 through the transseptal sheath 110 and into theleft atrium 10; bringing the distal end of the anchor delivery catheter112 into alignment and/or engagement with candidate locations fordeployment of the anchor 146; and determining if the candidate site issuitable. The steps may include: delivering and/or engaging the anchor146, which may be the first trigonal anchor; deploying the rail 160attached to the anchor 146; advancing the coaptation assistance device180 over the rail 160; delivering and/or engaging the second anchor 146,which may be a second trigonal anchor; deploying the rail 160 attachedto the second anchor; advancing the coaptation assistance device 180over the rail 160 of the first anchor 146 and the rail 160 of the secondanchor 146; facilitating placement of the coaptation assistance device180 with the rails 160; and positioning the coaptation assistance device180 over the posterior leaflet 32. The steps may include: extending thecoaptation assistance device 180 through the mitral valve 20 into theleft ventricle 14; expanding a ventricular anchor 208 of the coaptationassistance device 180; locking the coaptation assistance device 180 onthe one or more anchors 146 by the clip 192 and/or the pledget 194; andremoving the delivery system 106. These instructions can be written,oral, or implied.

Referring now to FIGS. 12A-12D, the method of clip 192 and pledget 194placement is shown. As shown in FIG. 12A, in some embodiments the clip192 and pledget 194 are initially loaded on the hypotube 196. A guidesuture 210 extends in a loop from the hypotube 196. The guide suture 210can engage the anchor suture 158. The anchor suture 158 is connected tothe anchor 146 as shown in FIG. 12A. The hypotube 196 is retracted intothe clip delivery catheter 116, as shown by the upward arrow in FIG.12B. The distal tip of the clip delivery catheter 116 pushes downward onthe clip 192, as shown by the downward arrow in FIG. 12B. The clip 192presses against the pledget 194 and both the clip 192 and the pledget194 are pressed downward by the clip delivery catheter 116. The clip 192and the pledget 194 are advanced along the anchor suture 158. Thecompression force of the clip 192 on the anchor suture 158 locks theclip 192 on the anchor suture 158. The pledget 194 is prevented fromtranslation along the anchor suture 158 by the locking of the clip 192.In some embodiments, the second hypotube 204 is pressed downward on theclip 192 and the pledget 194 instead of, or in addition to, the tip ofthe clip delivery catheter 116.

As shown in FIG. 12C, the guide suture 210 can extend from the hypotube196. In some embodiments, the hypotube 196 is crimped over the guidesuture 210. This crimping allows easy introduction of the clip 192and/or the pledget 194 over the guide suture 210. This crimping alsoensures a proper connection between the hypotube 196 and the anchor 146.After the clip 192 and/or the pledget 194 is locked, the guide suture210 can be cut and retracted through the clip delivery catheter 116, asshown in FIG. 12D.

The aforementioned method can be performed by a physician. In oneembodiment, a manufacturer can provide one, some or all of thefollowing: the clip 192, the pledget 194, the hypotube 196, the secondhypotube 204, the anchor 146, the anchor suture 158, the guide suture210, and clip delivery catheter 116. In some embodiments, themanufacture provides a kit containing some or all of the devicespreviously described.

In some embodiments, the manufacturer provides instructions for use ofthe system including one or more of the following steps, or any steppreviously described or inherent in the drawings. The steps may include:initially loading the clip 192 and/or the pledget 194 on the hypotube196; extending the guide suture 210 from the hypotube 196; engaging theguide suture 210 to the anchor suture 158; connecting the anchor suture158 to the anchor 146; retracting the hypotube 196 into the clipdelivery catheter 116; pressing the distal tip of the clip deliverycatheter 116 downward on the clip 192; pressing the clip 192 against thepledget 194; pressing both the clip 192 and the pledget 194 downward;and advancing the clip 192 and the pledget 194 along the anchor suture158. The steps may include: crimping the hypotube 196 over the guidesuture 210; cutting the guide suture 210 after the clip 192 is locked;and retracting the guide suture 210 through the clip delivery catheter116. These instructions can be written, oral, or implied.

Turning now to FIG. 13, an embodiment of the coaptation assistancedevice 280 is shown. The coaptation assistance device 280 can besubstantially similar to the coaptation assistance device 80, 180described herein. The coaptation assistance device 280 can include frame282 configured to provide structural support to the coaptationassistance device 280. In some embodiments, the frame 282 is collapsibleto fit within a delivery catheter, as described herein. In someembodiments, the frame 282 defines a superior edge 284. The frame 282can include anchor eyelets 286 configured to accept an anchor, such asanchor 146 or other trigonal anchors. The eyelets 286 can be integratedinto the surface of the coaptation assistance device 280 or coupled tothe coaptation assistance device 280 by any mechanism known in the art.The eyelets 286 correspond to the region of the coaptation assistancedevice 280 that may be secured to the anterior and posterior fibroustrigones 56, 60. In general, the trigones 56, 60 are locatedapproximately 1-10 mm lateral or medial to their respective commissures50, 52, and about 1-10 mm more anterior than the commissures 50, 52. Inother embodiments, different anchor arrangements may connect thesuperior edge 284 of the coaptation assistance device 280 can to ananchor, such as anchor 146. For instance, the superior edge 284 caninclude a hub (not shown) for an anchor to extent or a tether (notshown) connecting the anchor or a hub to the superior edge 284. In someembodiments, the medial end of a tether or the hub is connected to theeyelet 286.

Alternate engagement means are contemplated for connecting thecoaptation assistance device 280 to each anchor, including the eyelets286 and hubs (not shown), but also including other connection means suchas, for example, sutures, staples, adhesive or clips. In alternativeembodiments, the anchors may form an integrated part of the device. Insome embodiments, both anchors inserted within the eyelet 286 arehelical anchors. There are many possible configurations for anchoringmeans, compositions of anchors, and designs for anchoring means.

The coaptation assistance device 280 comprises a body 290. The body 290comprises a first surface 292 disposed toward a mal-coapting nativeleaflet, in the instance of a mitral valve 20, the posterior leaflet 32and a second surface 294 which may be disposed toward the anteriorleaflet 30. The first and second surfaces 292, 294 can be consideredcooptation surface. The coaptation assistance device 280 can have ageometry which permits it to traverse the mitral valve 20 betweenattachment sites in the left atrium 10 and/or the left ventricle 14, toprovide a coaptation surface 294 for the anterior leaflet 30 to coaptagainst, and attach to the left atrium 10 or annulus 36 such that iteffectively seals off the posterior leaflet 32. In the instance that theposterior leaflet 32 is or has been removed, the coaptation assistancedevice 280 replaces the posterior leaflet 32.

In some embodiments, the coaptation surface 292, 294 of the coaptationassistance device 280 passes superiorly and radially inwardly from thesuperior edge 284, before passing distally, in a longitudinal directionperpendicular to the valve plane, or radially inwardly or outwardly withrespect to the valve plane.

In some embodiments, the first surface 292 and the second surface 294 ofthe coaptation assistance device 280 further comprise a coveringcomprised of ePTFE, polyurethane foam, polycarbonate foam, biologictissue such as porcine pericardium, or silicone.

One possible frame 282 structure is shown, with frame 282 connecting theeyelets 286. Other frame elements may be incorporated into thecoaptation assistance device 280. The frame 282 may be shaped in anynumber of ways to assist in maintaining the desired shape and curvatureof the coaptation assistance device 280. The frame 282 can be made ofNitinol, stainless steel, polymer, or other appropriate materials, andcan substantially assist in maintain the geometry of the coaptationassistance device 280, permitting choice of any of a wide variety ofcovering materials best suited for long term implantation in the heartand for coaptation against the anterior leaflet 30.

The coaptation assistance device 280 may include one or a plurality ofanchors, such as anchor 146, to stabilize the coaptation assistancedevice 280. The coaptation assistance device 280 can also have aventricular anchor 296 (e.g., ribbons described herein). In someembodiments, the ventricular anchor 296 engages the area under theposterior leaflet 32. the atrial and/or ventricular anchors optionallyproviding redundant fixation. The anchors may include a plurality ofbarbs for acute fixation to the surrounding tissue. In otherembodiments, the anchors may comprise a plurality of helixes, clips,harpoon or barb-shaped anchors, or the like, appropriate for screwing orengaging the annulus 36 of the mitral valve 20, tissues of theventricle, and/or other tissues of the atrium, or the atrial orventricular anchors may attach to the tissue by welding using RF orother energy delivered via the elongate anchor coupling body.

In some embodiments, a ventricular anchor 296 may be included in theform of a tether or other attachment means extending from the valve 20thru the ventricle septum to the right ventricle 16, or through the apexinto the epicardium or pericardium, which may be secured from outsidethe heart in and combined endo/epi procedure. When helical anchors areused, they may comprise bio-inert materials such as Platinum/Ir, aNitinol alloy, and/or stainless steel.

Referring now to FIGS. 14A-14D, the implantation steps of one embodimentof the method is shown. As shown in FIG. 14A, a transseptal method fortreatment of MR can include gaining access to the left atrium 10 via thetransseptal sheath 110. Access to the femoral vein may be obtained usingthe Seldinger technique. From the femoral vein, access can then beobtained via the right atrium 12 to the left atrium 10 by a transseptalprocedure. A variety of conventional transseptal access techniques andstructures may be employed, so that the various imaging, guidewireadvancement, septal penetration, and contrast injection or otherpositioning verification steps need not be detailed herein.

Referring now to FIG. 14A, non-limiting candidate locations areillustrated for deployment of an anchor, such as anchor 146, optionallyunder guidance of 2D or 3D intracardiac, transthoracic, and/ortransesophageal ultrasound imaging, Doppler flow characteristics,fluoroscopic or X-ray imaging, or another imaging modality. In someembodiments, a guidewire is used to advance the anchors 146 to thedesired location. In some embodiment, a posteromedial trigonal anchor146 is placed and an anterolateral trigonal anchor 146 is placed usingthe guidewire.

As shown in FIG. 14B, the first and second trigonal anchors 146 aredelivered and engaged. The locations of the trigonal anchors 146 areshown in relationship to the anterior leaflet 30, the posterior leaflet32, and mitral valve 20 as shown. In some embodiments, each trigonalanchor 146 comprises at least one guidewire or rail 160 such that thecoaptation assistance device 280 can be advanced over the rails 160. Insome embodiments, the rails 160 advance through a portion of thecoaptation assistance device 280 and through the transseptal catheter110. In some embodiments, the rails 160 extend through eyelets 286.

It can be seen that in some embodiments, the coaptation assistancedevice 280 is collapsed inside the anchor delivery catheter 112. Theradially expandable and/or collapsible structure including frame 282,which can be stent-like in some embodiments, allows the implant to becollapsed. In some embodiments, the coaptation assistance device 280 iscollapsed and delivered through the transseptal catheter 110 over therails 160.

As shown, after two trigonal anchors 146 are delivered and received; thecoaptation assistance device 280 is advanced over two rails 160 as shownby the arrows in FIG. 14C. In this way, the rails 160 facilitateplacement of the coaptation assistance device 280. As the coaptationassistance device 280 is delivered over the rails 160, the coaptationassistance device 280 exits the implant delivery catheter 114, allowingthe coaptation assistance device 280 to be exposed and expanded.

The coaptation assistance device 280 can be delivered by the implantdelivery catheter 114 and may be capable of expanding from a smallerprofile to a larger profile to dimensions appropriate for placement inbetween the valve's native leaflets 30, 32. The coaptation assistancedevice 280 is expanded as it is exposed from the tip of the implantdelivery catheter 114 as shown. In some embodiments, the implantdelivery catheter 114 is pulled back to expose the coaptation assistancedevice 280. The coaptation assistance device 280 is advanced over theposterior leaflet 32.

As shown in FIG. 14C, the coaptation assistance device 280 can extendthrough the mitral valve 20 into the left ventricle 14. In someembodiments, the coaptation assistance device 280 may have a ventricularanchor 296 that is expanded to attach the coaptation assistance device280 to ventricular tissue. The ventricular anchor 296 of the coaptationassistance device 280 can be delivered by the implant delivery catheter114. A shown in FIG. 14D, the implant delivery catheter 114 is retractedinto the transseptal catheter 110. The ventricular anchor 296 of thecoaptation assistance device 280 is released and can assume a curvedshape as shown. After placement of the coaptation assistance device 280,in some embodiments, the coaptation assistance device 280 is locked onthe anchors 146 by one or more clips 192 and/or pledget 194, as shown inFIG. 14D. After the coaptation assistance device 280 is locked on theanchors 146, the catheter delivery system 106 is removed. In someembodiments, the rails 160 are also removed.

The aforementioned method can be performed by a physician. In oneembodiment, a manufacturer can provide one, some or all of thefollowing: coaptation assistance device 280, transseptal sheath 110,anchor delivery catheter 112, implant delivery catheter 114, and clipdelivery catheter 116. In some embodiments, the manufacturer provides akit containing some or all of the devices previously described.

In some embodiments, the manufacturer provides instructions for use ofthe system including one or more of the following steps, or any steppreviously described or inherent in the drawings. The steps may include:gaining access to the left atrium 10 via a transseptal sheath 110;gaining access to the femoral vein via the Seldinger technique; gainingaccess via the right atrium 12 to the left atrium 10 by a transseptalprocedure, utilizing a variety of conventional transseptal accesstechniques and structures. The steps may include: positioning thetransseptal sheath 110 within the left atrium 10; deploying an anchordelivery catheter 112 through the transseptal sheath 110 and into theleft atrium 10; bringing the distal end of the anchor delivery catheter112 into alignment and/or engagement with candidate locations fordeployment of an anchor 146; and determining if the candidate site issuitable. The steps may include: collapsing the coaptation assistancedevice 280 inside the implant delivery catheter 114; delivering thecoaptation assistance device 280 through the transseptal sheath 110 overthe rails 160; expanding the coaptation assistance device 280 as itexits the implant delivery catheter 114; and retracting the implantdelivery catheter 114. The steps may include: delivering and/or engagingthe anchor 146, which may be the first trigonal anchor; deploying a raid160 attached to each anchor 146; advancing the coaptation assistancedevice 280 over the rail 160; delivering and/or engaging the secondanchor 146, which may be the second trigonal anchor; deploying the rail160 attached to the second anchor; advancing the coaptation assistancedevice 180 over the rails 160 delivering and/or engaging the secondanchor 146; facilitating placement of the coaptation assistance device180; and positioning the coaptation assistance device 180 over theposterior leaflet 32. The steps may include: extending the coaptationassistance device 180 through the mitral valve 20 into the leftventricle 14; expanding a ventricular anchor 296 of the coaptationassistance device 180; locking the coaptation assistance device 180 onthe anchors 146 by one or more clips 192 and/or pledgets 194; andremoving the catheter delivery system 106. These instructions can bewritten, oral, or implied.

Turning now to FIG. 15, an embodiment of the coaptation assistancedevice 380 is shown. The coaptation assistance device 380 can besubstantially similar to the coaptation assistance device 80, 180, 280described herein. The coaptation assistance device 380 can include frame382 configured to provide structural support to the coaptationassistance device 380. In some embodiments, the frame 382 is collapsibleto fit within a delivery catheter, such as implant delivery catheter114. In some embodiments, the frame 382 defines a superior edge 384. Theframe 382 can include anchor eyelets 386 configured to accept an anchor,such as anchor 146. In some embodiments, such as shown in FIG. 15, theeyelets 386 are configured to accept a commissure anchor 390. Commissureanchor locations are provided, such as at lateral ends of an arcuatebody portion of the coaptation assistance device 380 as shown. In someembodiments, the commissure anchor 390 is substantially similar oridentical to the anchor 146 described herein. The eyelets 386 can beintegrated into the surface of the coaptation assistance device 380 orcoupled to the coaptation assistance device 380 by any mechanism knownin the art. The eyelets 386 correspond to the region of the coaptationassistance device 280 that may be secured to the lateral commissures 50,52. In other embodiments, different anchor arrangements may connect theframe 382 of the coaptation assistance device 280 to anchors. In otherembodiments, different anchor arrangements may connect the frame 282and/or edge of the coaptation assistance device 380 to the correspondinganatomic structure. In some embodiments, one or more of the commissureanchors 390 are helical anchors, as shown. There are many possibleconfigurations for anchoring, compositions of anchors, and designs as,for example, previously described.

The coaptation assistance device 380 comprises a body 392, which may beconfigured to permit relatively normal circulation of blood in theventricular chamber. The body 392 may be elongate and narrow between theanterior and posterior surfaces, taking up minimal space and allowingmovement of blood from one side to another and past both lateral aspectsof the coaptation assistance device 380.

The coaptation assistance device 380 may include one or a plurality ofventricular anchors 394. The atrial anchors and ventricular anchors canoptionally provide redundant fixation. The atrial anchors may include aplurality of barbs for acute fixation to the surrounding tissue. Inother embodiments, the atrial anchors may comprise a plurality ofhelixes, clips, harpoon or barb-shaped anchors, or the like, appropriatefor engaging tissues of the ventricle. As shown in FIG. 15, theventricular anchor can comprise two ribbons 396 that rest against thewall of the left ventricle 14. While two ribbons 396 are shown, in someembodiments one or more ribbons 396 are used (e.g., one, two, three,four etc.). This position may provide stability of the coaptationassistance device 380 and/or the base 398 of the coaptation assistancedevice 380. When ventricular anchors 394 are used, they may comprisebio-inert materials such as, for example, Platinum/Ir, a Nitinol alloy,and/or stainless steel. In some embodiments, the ribbons 396 compriseNiTi. In some embodiments, the ribbons 396 have a pre-determined curve.The material selection combined with the selected shape provides aventricular anchor 394 that is spring loaded. In some embodiments, thespring loaded ribbons 396 engage tissues of the left ventricle 14 asshown. Each ribbon 396 can form, for example, a generally U-shapedconfiguration. The ribbons 396 function as anchors and resist movementof the coaptation assistance device 380. The ribbons 396 together canform a generally W-shaped configuration. The ribbons 396 comprise arounded surface configured to abut tissue. In some embodiments, theanchors abut tissue and can exert a force on the tissue to stabilize thecoaptation assistance device 380, but do not penetrate through one ormore tissue layers, e.g., the endocardium or myocardium. In someembodiments, the anchors include a pair of arms with a bias that when inan unstressed configuration can clip onto a portion of the ventricularwall to stabilize the coaptation assistance device, such as in anon-traumatic manner with respect to the ventricular wall. The size andshape of the ribbons can be determined based upon the dimensions of theleft ventricle 14, and the left ventricle wall which the ribbons 396 mayabut. The ribbons 396 can be generally parallel to the base of theposterior leaflet 32. Other shapes for the ribbons 396 are contemplated.As disclosed herein, the coaptation assistance device 380 is collapsedinside the delivery catheter, such as implant delivery catheter 114. Thespring loaded ribbons 396 are capable of being collapsed within thedelivery catheter. Upon exiting the catheter, the spring loaded ribbons396 rapidly expand into the preformed shape. In some embodiments, theribbons 396 are provided for ventricular attachment. The ribbons 396allow for very rapid attachment of the coaptation assistance device 380to the tissue, since the ribbons 396 do not rely on annular sutures anddo not require tying knots. The deployment of the ribbons 396 can befaster than engaging a helical anchor, for instance.

Turning now to FIG. 16, an embodiment of the coaptation assistancedevice 480 is shown. The coaptation assistance device 480 can besubstantially similar to the coaptation assistance device 80, 180, 280,380 described herein. The coaptation assistance device 480 can includeframe 482 configured to provide structural support to the coaptationassistance device 480. In some embodiments, the frame 482 is collapsibleto fit within a delivery catheter, such as implant delivery catheter114. In some embodiments, the frame 482 defines a superior edge 484. Theframe 482 can include anchor eyelets 486 configured to accept an anchor,such as anchor 146. In some embodiments, such as shown in FIG. 16, theeyelets 486 are configured to accept an anchor 490. A plurality oflocations for eyelets 486 are provided as shown in FIG. 16. In otherembodiments, different anchor arrangements may connect the edge of thecoaptation assistance device 480 to the corresponding anatomicstructure. In some embodiments, the anchors 490 are helical anchors, asshown. There are many possible configurations for anchoring means,compositions of anchors, and designs for anchoring means. In someembodiments, the anchor 490 can be substantially similar or identical toanchor 146.

The coaptation assistance device 480 may include one or a plurality ofatrial anchors 490 and ventricular anchors 494, with the anchorsoptionally providing redundant fixation. In some embodiments, the atrialanchors 490 may comprise a plurality of helixes, clips, harpoon orbarb-shaped anchors, or the like, appropriate for engaging tissues ofthe ventricle. The atrial anchors 490 may extend through the posteriorleaflet as shown. As shown in FIG. 16, the ventricular anchor 494comprises a plurality of, e.g., three spring-loaded clips or ribbons 496configured to engage at least a portion of a mitral valve 20, e.g., aportion of posterior leaflet 32 resides in between the ribbons 496 andthe body 482. A clip or ribbon can has a bias (e.g., by virtue of itsshape memory properties) such that one, two, or more surfaces exert aforce, such as a compressive force, on a body structure such as a valveleaflet as shown sufficient to anchor the implant in place. For example,a first portion of a clip can apply a force against a first surface of avalve leaflet as illustrated, and a second portion of the clip can applya force or rest against a second side of the leaflet, the second side ofthe leaflet opposite the first side of the leaflet. While three ribbons496 are shown, in some embodiments any number of ribbons 496 can be used(e.g., one, two, three, four, etc.). This position may provide stabilityof the coaptation assistance device 480 and/or the implant base 498.This position may not require additional anchoring of the coaptationassistance device to the ventricle 14 or elsewhere. When ribbons 496 areused, they may comprise, e.g., bio-inert materials such as Platinum/Ir,a Nitinol alloy, and/or stainless steel. In some embodiments, theribbons 496 comprise NiTi. In some embodiments, the ribbons 496 have apre-determined curve. The material selection combined with the selectedshape provides a ventricular anchor 496 that is spring loaded. Theribbons 496 rest against the posterior leaflet, as shown. In someembodiments, the spring loaded ribbons 496 engage other tissues of themitral valve. Each ribbon 496 can form a generally S-shapedconfiguration. The ribbons 496 function as anchors and resist movementof the coaptation assistance device 480. The ribbons 496 comprise arounded surface configured to abut tissue. The size and shape of theribbons 496 can be determined based upon the dimensions of the posteriorleaflet 32 which the ribbons 496 may abut. The ribbons 496 can begenerally parallel to the tip of the posterior leaflets 32. Other shapesfor the ribbons 496 are contemplated. As disclosed herein, thecoaptation assistance device 480 is collapsed inside the deliverycatheter. The spring loaded ribbons 496 are capable of being collapsedwithin the delivery catheter, such as implant delivery catheter 114.Upon exiting the catheter, the spring loaded ribbons 496 rapidly expandinto the preformed shape. In some embodiments, the ribbons 496 areprovided for ventricular attachment. The ribbons 496 allow for veryrapid attachment of the coaptation assistance device 480 to the tissue,since the ribbons 496 do not rely on annular sutures and do not requiretying knots. The deployment of the ribbons 496 can be faster thanengaging a helical anchor, for instance.

In an alternative embodiment, the ribbons 500 are provided. The ribbons500 extend to the base of the posterior leaflet 32 and align with theanchor 490. The anchor 490 positioned on the posterior leaflet 32 maypenetrate the leaflet 32 and connect with the ribbon 500. Alternatively,anchors 490 positioned on the ribbons 500 may penetrate the posteriorleaflet from the opposite direction. In some embodiments, the anchor 490can engage the upper, left atrium side of the coaptation assistancedevice 480 and the ribbons 500 located in the left ventricle. Thisconfiguration may improve the stability of the coaptation assistancedevice 480. Each ribbon 500 can form a generally L-shaped configuration.The ribbons 500 comprise a rounded surface configured to abut theventricular side of the posterior leaflet 32. The size and shape of theribbons can be determined based upon the dimensions of the posteriorleaflet 32 which the ribbons 500 may abut. The ribbons 500 can begenerally parallel to the tip of the posterior leaflet 32. Other shapesfor the ribbons 500 are contemplated. As disclosed herein, thecoaptation assistance device 480 is collapsed inside the deliverycatheter. The spring loaded ribbons 500 are capable of being collapsedwithin the delivery catheter, such as implant delivery catheter 114.Upon exiting the catheter, the spring loaded ribbons 500 rapidlytransform from a first compressed configuration into the preformed shapeof the second expanded configuration. In some embodiments, the clips orribbons 500 are linear or substantially linear in a compressedconfiguration. In some embodiments, the ribbons 500 are provided forventricular attachment. The ribbons 500 allow for very rapid attachmentof the coaptation assistance device 480 to the tissue, since the ribbons500 do not rely on annular sutures and do not require tying knots. Thedeployment of the ribbons 500 can be faster in some cases than engaginga helical anchor, for instance.

In some embodiments, the clips or ribbons as disclosed in connectionwith various embodiments herein can be advantageously utilized with awide variety of cardiac implants not limited to the coaptationassistance devices disclosed herein. For example, the clips or ribbonscan be operably connected to replacement heart valves such as mitral oraortic valves, for example, for anchoring and stabilization. In someembodiments, the clips or ribbons can exert a force to clip or otherwiseattach onto one or more native valve leaflets, in order to anchor areplacement heart valve in the valve annulus.

Turning now to FIGS. 17A-17B, an embodiment of the coaptation assistancedevice 580 is shown. The coaptation assistance device 580 can besubstantially similar to the coaptation assistance device 80, 180, 280,380, 480 described herein. The coaptation assistance device 580 caninclude frame 582 configured to provide structural support to thecoaptation assistance device 580. In some embodiments, the frame 582 iscollapsible to fit within a delivery catheter, such as implant deliverycatheter 114. In some embodiments, the frame 582 defines a superior edge584. The frame 582 can include anchor eyelets 586 configured to acceptan anchor, such as anchor 146. In some embodiments, such as shown inFIG. 17, the eyelets 586 are configured to accept a trigonal anchor suchas anchor 146. In some embodiments, the eyelets 586 correspond to theregion of the coaptation assistance device 580 that may be secured tothe anterior and posterior fibrous trigones 56, 60. In some embodiments,the coaptation assistance device 580 comprises a ventricular anchor hub590. In some embodiments, the hub 590 provides an attachment structurefor a ventricular anchor 594.

The coaptation assistance device 580 comprises a body 592. The body 592comprises a first surface 596 disposed toward a mal-coapting nativeleaflet, in the instance of a mitral valve 20, the posterior leaflet 32and a second surface 598 which may be disposed toward the anteriorleaflet 30. The first and second surfaces 596, 598 can be consideredcooptation surface. The coaptation assistance device 580 can have ageometry which permits it to traverse the mitral valve 20 betweenattachment sites in the left atrium 10 and left ventricle 14, to providea coaptation surfaces 598 for the anterior leaflet 30 to coapt against,and attach to the atrium 10 or annulus 36 such that it effectively sealsoff the posterior leaflet 32. In the instance that the posterior leaflet32 is or has been removed, the coaptation assistance device 580 replacesthe posterior leaflet 32.

In some embodiments, the coaptation surface 598 of the coaptationenhancement element passes superiorly and radially inwardly from thesuperior edge, before passing distally, in a longitudinal directionperpendicular to the valve plane, or radially inwardly or outwardly withrespect to the valve plane.

In some embodiments, the anterior surface 598 and posterior surface 596of the coaptation assist device 580 further comprise a coveringcomprised of ePTFE, polyurethane foam, polycarbonate foam, biologictissue such as porcine pericardium, or silicone.

One possible frame 582 is shown, with frame connecting the eyelets 586.Other frame elements may be incorporated into the coaptation assistancedevice 580. The frame 582 may be shaped in any number of ways to assistin maintaining the desired shape and curvature of the coaptationassistance device 580. The frame can be made of Nitinol, stainlesssteel, polymer or other appropriate materials, can substantially assistin maintain the geometry of the coaptation assistance device 580,permitting choice of any of a wide variety of covering materials bestsuited for long term implantation in the heart and for coaptationagainst the anterior leaflet 30.

The coaptation assistance device 580 may include one or a plurality ofanchors to stabilize the coaptation assistance device 580, with theanchors optionally providing redundant fixation. The anchors may includea plurality of barbs for acute fixation to the surrounding tissue. Inother embodiments, the anchors may comprise a plurality of helixes,clips, harpoon or barb-shaped anchors, or the like, appropriate forscrewing or engaging into the annulus of the mitral valve 20, tissues ofthe left ventricle 14, and/or other tissues of the left atrium 10. Theanchors may attach to the tissue by welding using RF or other energydelivered via the elongate anchor coupling body.

Referring now to FIGS. 18A-18C, the implantation steps of one embodimentof the method is shown. As shown in FIG. 18A, a delivery catheter 600 isadvanced into the left atrium 10. The delivery catheter 600 can besubstantially similar to implant delivery catheter 114. In someembodiments, the delivery catheter 600 may be advanced through the outertransseptal sheath 110 and into the left atrium 10. FIG. 18A shows anembodiment of the delivery catheter 600. The delivery catheter 600 mayinclude a shaft 602 made of a polymer for example. In some embodiments,the shaft 602 is a braid or coil reinforced polymer shaft. In someembodiments, the shaft 602 has multiple durometers. In otherembodiments, the delivery catheter 600 comprises an actively deflectabletip 604 to facilitate navigation of one or more anchors 594 to theanchoring sites. For instance, the deflectable tip 604 can access thesite under the posterior leaflet. The delivery catheter 600 may includea deflection knob 606 to control the deflectable tip 604.

The delivery catheter may include a drive shaft 610. The drive shaft 610has a feature at the tip to engage with and allow transmission of torqueto the anchor 594. In some embodiments, the drive shaft 610 is flexible.In some embodiments, the drive shaft 610 is capable of being advanced orretracted. The delivery catheter 600 may include a knob 612 that isconnected to the drive shaft 610. The knob 612 is internally connectedto the drive shaft 610 thereby allowing transmission of torque to theanchor 594 when the knob 612 is rotated. This enables simplemanipulation of the anchor position and torque.

The coaptation assistance device 580 can be delivered by the deliverycatheter 600 and may be capable of expanding from a smaller profile to alarger profile to dimensions appropriate for placement in between thevalve's native leaflets 30, 32. The coaptation assistance device 580 isexpanded as it is exposed from the tip of the delivery catheter 600. Insome embodiments, the delivery catheter 600 is pulled back to expose thecoaptation assistance device 580. The delivery catheter 600 may furtherinclude a control handle 614 to manipulate the coaptation assistancedevice 580 and/or, to manipulate the docking and undocking of thecoaptation assistance device 580 with the delivery catheter 600 and/orto facilitate placement of the coaptation assistance device 580.

Referring now to FIG. 18A, the distal end of the delivery catheter 600moves within the left atrium 10 by manipulating the control handle 614and by articulating the actuator of deflection knob 612 so as toselectively bend the deflectable tip 604 and/or the distal end of thedelivery catheter 600. The deflectable tip 604 and/or the distal end ofthe delivery catheter 600 can be brought into alignment and/orengagement with candidate locations for deployment of the anchor 594.The deflectable tip 604 and/or distal end of the delivery catheter 600can be deflected to access the site under the posterior leaflet 32. Insome embodiments, the distal end of the delivery catheter 600 is broughtinto alignment with the wall of the left ventricle 14 to facilitateplacement of the ventricle hub 590 and/or ventricle anchor 594.

As shown in FIG. 18A, the trigonal anchors 146 are delivered and engagedas described herein. The coaptation assistance device 580 is extendedthrough the mitral valve 20 into the left ventricle 14. In someembodiments, the coaptation assistance device 580 may have a ventricularhub 590 and/or ventricular anchor 594. The ventricular anchor 594 asshown is a helical anchor, but other anchor designs are contemplated. Insome embodiments, the ventricular anchor 594 extends from the leftventricle 14 to the left atrium 10 as shown.

As shown in FIGS. 18B-18C, the coaptation assistance device 580 isanchored and the delivery catheter 600 is removed. The coaptationsurface 598 is placed between the anterior leaflet 30 and the posteriorleaflet 32. The ventricular anchor 594 and the trigonal anchors 146 aresecured. In some embodiments, there is an anteriolateral trigonal anchor146 and a posteriomedial trigonal anchor 146 as shown in FIG. 18C.

The aforementioned method can be performed by a physician. In oneembodiment, the manufacturer can provide one, some or all of thefollowing: coaptation assistance device 580, delivery catheter 600,trigonal anchor 146, and ventricular anchor 594. In some embodiments,the manufacturer provides a kit containing some or all of the devicespreviously described.

In some embodiments, the manufacturer provides instructions for use ofthe system including one or more of the following steps, or any steppreviously described or inherent in the drawings. The steps may include:positioning the delivery catheter 600 within the left atrium 10;bringing the deflectable tip 604 and/or the distal end of the deliverycatheter 600 into alignment and/or engagement with candidate locationsfor deployment of an anchor; and determining if the candidate site issuitable. The steps may include: delivering and/or engaging the firsttrigonal anchor 146; delivering and/or engaging the second trigonalanchor 146; facilitating placement of the coaptation assistance device580; and positioning the coaptation assistance device 580 over theposterior leaflet. The steps may include: extending the coaptationassistance device 580 through the mitral valve 20 into the leftventricle 14; locking the coaptation assistance device 580 on thetrigonal anchors 146 by one or more clips 192 and/or pledgets 194; andremoving the catheter delivery system. These instructions can bewritten, oral, or implied.

It is contemplated that various combinations or subcombinations of thespecific features and aspects of the embodiments disclosed above may bemade and still fall within one or more of the inventions. Further, thedisclosure herein of any particular feature, aspect, method, property,characteristic, quality, attribute, element, or the like in connectionwith an embodiment can be used in all other embodiments set forthherein. Accordingly, it should be understood that various features andaspects of the disclosed embodiments can be combined with or substitutedfor one another in order to form varying modes of the disclosedinventions. Thus, it is intended that the scope of the presentinventions herein disclosed should not be limited by the particulardisclosed embodiments described above. Moreover, while the invention issusceptible to various modifications, and alternative forms, specificexamples thereof have been shown in the drawings and are hereindescribed in detail. It should be understood, however, that theinvention is not to be limited to the particular forms or methodsdisclosed, but to the contrary, the invention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the various embodiments described and the appended claims.Any methods disclosed herein need not be performed in the order recited.The methods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “inserting a coaptation assist body proximate the mitralvalve” includes “instructing the inserting of a coaptation assist bodyproximate the mitral valve.” The ranges disclosed herein also encompassany and all overlap, sub-ranges, and combinations thereof. Language suchas “up to,” “at least,” “greater than,” “less than,” “between,” and thelike includes the number recited. Numbers preceded by a term such as“approximately”, “about”, and “substantially” as used herein include therecited numbers, and also represent an amount close to the stated amountthat still performs a desired function or achieves a desired result. Forexample, the terms “approximately”, “about”, and “substantially” mayrefer to an amount that is within less than 10% of, within less than 5%of, within less than 1% of, within less than 0.1% of, and within lessthan 0.01% of the stated amount.

1-20. (canceled)
 21. An implant for treating mal-coaptation of a heartvalve, the heart valve having an annulus and posterior and anteriorleaflets with an open configuration and a closed configuration, theimplant comprising: a coaptation assist body comprising a superior edge,an inferior edge, and lateral edges that bound a first surface and asecond surface, the first surface configured to be disposed toward theposterior leaflet, the second surface configured to be disposed towardthe anterior leaflet to allow the anterior leaflet to coapt with thecoaptation assist body, the coaptation assist body comprising a centralorifice spaced inward from the superior edge, the inferior edge, and thelateral edges, the coaptation assist body surrounding the centralorifice, a plurality of ribbons configured to engage tissue, theplurality of ribbons comprising at least one curve, the plurality ofribbons movable from a first compressed configuration to a secondexpanded configuration; and an atrial anchor comprising a helical bodyconfigured to extend through the central orifice and into the annulus.22. The implant of claim 21, wherein at least one ribbon of theplurality of ribbons comprise two discrete curves.
 23. The implant ofclaim 21, wherein the plurality of ribbons are configured to restagainst the tissue of the heart.
 24. The implant of claim 21, whereinthe plurality of ribbons resist movement of the coaptation assist bodywithout penetrating the myocardium.
 25. The implant of claim 21, whereinthe plurality of ribbons comprise Nitinol.
 26. The implant of claim 21,wherein the atrial anchor comprises an outer diameter between 1 mm and 6mm.
 27. The implant of claim 21, wherein the atrial anchor comprises apitch of 0.4 mm to 1.5 mm.
 28. The implant of claim 21, wherein theatrial anchor comprises a wire.
 29. The implant of claim 28, wherein thewire comprises a diameter of 0.25 mm to 0.75 mm.
 30. The implant ofclaim 21, wherein the atrial anchor comprises a drive continuationextending proximally from the helical body.
 31. The implant of claim 21,further comprising a secondary anchor.
 32. An implant for treatingmal-coaptation of a heart valve, comprising: an implant body configuredto improve function of the heart valve, the implant body comprising asuperior edge, an inferior edge, and lateral edges that bound a firstsurface and a second surface, the first surface configured to bedisposed toward a posterior leaflet and the second surface configured tobe disposed toward an anterior leaflet, the implant body comprising adiscrete opening spaced inward from the superior edge, the inferioredge, and the lateral edges, a plurality of ribbons, the plurality ofribbons comprising a shape memory material comprising at least onecurve, the plurality of ribbons movable from a first compressedconfiguration to a second expanded configuration; and an atrial anchorcomprising a helical body, wherein the helical body is configured to berotated relative to the discrete opening to be driven into tissue. 33.The implant of claim 32, wherein the implant body is configured totraverse the mitral valve.
 34. The implant of claim 32, wherein theimplant body comprises an attachment site in the left atrium.
 35. Theimplant of claim 32, wherein the implant body comprises an attachmentsite in the left ventricle.
 36. The implant of claim 32, wherein thesecond surface comprises a coaptation surface for the anterior leafletto coapt against.
 37. The implant of claim 32, wherein the implant bodyis configured to attach to the left atrium or annulus.
 38. The implantof claim 32, wherein the implant body effectively seals off or replacesthe posterior leaflet.
 39. An implant for treating mal-coaptation of aheart valve, the heart valve having an annulus and posterior andanterior leaflets with an open configuration and a closed configuration,the implant comprising: a coaptation assist body having a first surfaceconfigured to be disposed toward the posterior leaflet, an opposedsecond surface configured to be disposed toward the anterior leaflet toallow the anterior leaflet to coapt with the coaptation assist body, thecoaptation assist body comprising a superior edge, an inferior edge, andlateral edges extending between the superior edge and the inferior edge,the coaptation assist body comprising a primary opening spaced inwardfrom the superior edge, the inferior edge, and lateral edges, thecoaptation assist body comprising a secondary opening laterally disposedfrom the primary opening, a plurality of ribbons, the plurality ofribbons comprising a shape memory material comprising at least onecurve, the plurality of ribbons movable from a first compressedconfiguration to a second expanded configuration; and a primary anchorcomprising a helical body, wherein the primary opening is configured toreceive the primary anchor.
 40. The implant of claim 39, furthercomprising a secondary anchor, wherein the secondary opening isconfigured to receive the secondary anchor.